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Sponsors and Collaborators: |
The John A. Hartford Foundation Atlanta VA Medical Center |
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Information provided by: | Atlanta VA Medical Center |
ClinicalTrials.gov Identifier: | NCT00866710 |
Background: Parkinson's disease affects up to 3% of persons over the age of 65. Lower urinary tract symptoms are a frequent cause of diminished quality of life in elderly persons and occur in up to 40% of persons with Parkinson's disease. While the exact mechanisms have not been determined, detrusor hyperactivity (hyperactivity of the bladder muscle) leading to symptoms of overactive bladder and urge incontinence is common. Behavioral and exercise-based therapies have relatively no side effects and have been shown to be an effective treatment for urge symptoms of overactive bladder in the aged population.
Hypothesis and Specific Aims: Behavioral therapy with computer assisted biofeedback and pelvic floor muscle exercises will result in a 50% decrease in the number of incontinence episodes in elderly persons (age > 50) with Parkinson's disease. The specific aims for this pilot study include the following:
Methods: Participants will be enrolled in an 8-week treatment trial of behavioral therapies and pelvic floor muscle exercises with computer-assisted biofeedback. Voiding diaries as well as urinary symptom and quality of life questionnaires will be used to assess response.
If persons with Parkinson's disease can complete the treatment trial and achieve a reduction in episodes of urinary incontinence with behavioral techniques this would lay the foundation for a larger, placebo-controlled trial. Assessment of responsiveness associated with severity of Parkinson's disease would also provide important information about the utility of this treatment strategy.
Condition | Intervention |
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Urinary Incontinence Parkinson's Disease |
Other: Exercise-based behavioral therapy |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Behavioral Therapy to Treat Urinary Incontinence in Parkinson's Disease |
Estimated Enrollment: | 20 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria:
Contact: Zobair Nagamia, MD | 404 321 6111 ext 5308 | zobair.nagamia@va.gov |
United States, Georgia | |
Atlanta VA Medical Center | Recruiting |
Atlanta, Georgia, United States, 30033 |
Principal Investigator: | Elizabeth C Vaughan, MD | Birmingham/Atlanta VA Geriatric Research Education and Clinical Center & Emory University |
Responsible Party: | Birmingham/Atlanta VA GRECC & Emory University ( Elizabeth Camille Vaughan, MD ) |
Study ID Numbers: | 6-38941 |
Study First Received: | March 19, 2009 |
Last Updated: | March 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00866710 History of Changes |
Health Authority: | United States: Institutional Review Board; United States: Federal Government |
Signs and Symptoms Ganglion Cysts Urologic Diseases Movement Disorders Urination Disorders Parkinson Disease |
Basal Ganglia Diseases Central Nervous System Diseases Urinary Incontinence Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |
Urination Disorders Basal Ganglia Diseases Nervous System Diseases Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Urological Manifestations |
Signs and Symptoms Urologic Diseases Parkinson Disease Movement Disorders Urinary Incontinence Parkinsonian Disorders |